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Int Health. 2013 Mar;5(1):64-71. doi: 10.1093/inthealth/ihs009. Epub 2012 Dec 30.

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.

Author information

1
National AIDS Research Institute, Indian Council of Medical Research, Pune, India.

Abstract

BACKGROUND:

Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India.

METHODS:

As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension.

RESULTS:

The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension.

CONCLUSIONS:

We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.

KEYWORDS:

Comprehension; Consent comprehension tool; Illiteracy; India; Informed consent process; Study related risks

PMID:
24029848
PMCID:
PMC3889625
DOI:
10.1093/inthealth/ihs009
[Indexed for MEDLINE]
Free PMC Article
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